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Chet French Manager, Global Safety Amylin Pharmaceuticals, Inc.  November 2007 Lessons Learned: cGMP Case Studies
cGMP Case Studies Training Session Agenda  ,[object Object],[object Object],[object Object],[object Object],[object Object]
21 CFR Parts 210/211 cGMPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
cGMPs Raising the  “Bar of Expectations ” Tragedies Technology Evolution The Bar of Expectations
cGMPs “Raising the Bar”
Regulations:  Good  or  Bad ?
Regulations:  Good  or  Bad ?  Medical Mistakes
Regulations:  A  Good  or  Bad?   Medical Mistakes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IV Bottle Contamination Case ,[object Object],[object Object]
IV Bottle Contamination Case Background ,[object Object],[object Object],[object Object],[object Object],[object Object]
IV Bottle Contamination Case Background ,[object Object],[object Object],[object Object],[object Object]
Abbott Laboratories Company Background 1970 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IV Bottle Contamination Case IV-Associated Septicemias 1970-1971 Week of Onset 9/26/70 3/13/71 1/23/71
IV Bottle Contamination Case Abbott Laboratories   IV Bottle -  New Cap Design 1970 Abbott Laboratories USP 5% Dextrose  Saline
IV Bottle Contamination Case   Abbott Laboratories   IV Bottle  -  New Cap Design 1970 Elastomer Liner Old Design Metal Slip Disc Glue Plastic Disc New Design Metal Slip Disc Red Rubber Disc Gilsonite
IV Bottle Contamination Case Contamination Intrusion
IV Bottle Contamination Case Outcome ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IV Bottle Contamination Case Investigation Findings and Recommendations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IV Bottle Contamination Case Applicable cGMPs ,[object Object],[object Object],[object Object],[object Object]
IV Bottle Contamination Case Summary ,[object Object],[object Object]
[object Object],[object Object],Hemodialysis Filter Case
Hemodialysis Filter Case Timeline ,[object Object],[object Object],[object Object],[object Object],[object Object]
Hemodialysis Filter Case  Commonality Observed ,[object Object]
Baxter Pharmaceuticals Background Information - 2001   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Hemodialysis Filter Case  Timeline (cont.) ,[object Object],[object Object],[object Object]
Hemodialysis Filter Case  Timeline (cont.) ,[object Object],[object Object],[object Object],[object Object]
Hemodialysis Filter Case  Timeline (cont.) ,[object Object],[object Object],[object Object],[object Object]
Hemodialysis  Filter Case  Manufacturing Process PASS Filter Integrity QC Test FAIL PASS Filter Integrity Retest With PF-5070 H 2 O FAIL QC FAIL
PF- 5070 Chemical Properties   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dialysis Filter Case  Outcome ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Hemodialysis Filter Case Summary ,[object Object],[object Object]
Proventil ®   Asthma Inhaler Case ,[object Object],[object Object]
Schering-Plough Company Background ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Schering-Plough Proventil ®   Asthma Inhaler Timeline 1998  1999  2000  2001 …  Q3  Q4   Q1  Q2  Q3  Q4  Q1  Q2  Q3  Q4  Q1  Q2  Q3  …  Puerto Rico IRE Kenilworth NJ Puerto Rico Kenilworth NJ 190K Units 60MM Units FDA FDA AAC FDA
Schering-Plough Proventil ®   Asthma Inhaler Deaths 1998-2000 1998 1999 2000 Recall 1 Recall 2
Schering-Plough AAC Audit   Findings -- Kenilworth, NJ Plant ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Schering-Plough Public Citizen’s Health Research Group  Letters ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Proventil ®   Asthma Inhaler Case   Outcome ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Proventil ®   Asthma Inhaler Case   FDA Compliance Inspectional Outcomes FDA 483 Form Establishment  Inspection Report Warning Letter Consent Decree NOIR Regulatory Action Continued  Operation No Regulatory  Action Criminal Charges
Proventil ®   Asthma Inhaler Case   Applicable cGMPs ,[object Object],[object Object],[object Object],[object Object]
How Could This Happen? ,[object Object],[object Object],[object Object],[object Object],[object Object]
What About Amylin? ,[object Object],[object Object],[object Object],[object Object]
Why Follow cGMPs? ,[object Object],[object Object],[object Object],[object Object]
Some Final Thoughts… ,[object Object],[object Object]
Q & A ,[object Object],? ? ?  ? ?

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cGMP Case Study Training

  • 1. Chet French Manager, Global Safety Amylin Pharmaceuticals, Inc. November 2007 Lessons Learned: cGMP Case Studies
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  • 4. cGMPs Raising the “Bar of Expectations ” Tragedies Technology Evolution The Bar of Expectations
  • 6. Regulations: Good or Bad ?
  • 7. Regulations: Good or Bad ? Medical Mistakes
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  • 13. IV Bottle Contamination Case IV-Associated Septicemias 1970-1971 Week of Onset 9/26/70 3/13/71 1/23/71
  • 14. IV Bottle Contamination Case Abbott Laboratories IV Bottle - New Cap Design 1970 Abbott Laboratories USP 5% Dextrose Saline
  • 15. IV Bottle Contamination Case Abbott Laboratories IV Bottle - New Cap Design 1970 Elastomer Liner Old Design Metal Slip Disc Glue Plastic Disc New Design Metal Slip Disc Red Rubber Disc Gilsonite
  • 16. IV Bottle Contamination Case Contamination Intrusion
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  • 28. Hemodialysis Filter Case Manufacturing Process PASS Filter Integrity QC Test FAIL PASS Filter Integrity Retest With PF-5070 H 2 O FAIL QC FAIL
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  • 34. Schering-Plough Proventil ® Asthma Inhaler Timeline 1998 1999 2000 2001 … Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 … Puerto Rico IRE Kenilworth NJ Puerto Rico Kenilworth NJ 190K Units 60MM Units FDA FDA AAC FDA
  • 35. Schering-Plough Proventil ® Asthma Inhaler Deaths 1998-2000 1998 1999 2000 Recall 1 Recall 2
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  • 39. Proventil ® Asthma Inhaler Case FDA Compliance Inspectional Outcomes FDA 483 Form Establishment Inspection Report Warning Letter Consent Decree NOIR Regulatory Action Continued Operation No Regulatory Action Criminal Charges
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Editor's Notes

  1. Potential talking points: